Solmed TubeFlex 4502 tubing Solmed TubeFlex 4502 Overig.pdfJM BioConnect bv P.O. Box 6286 • 5600...

JM BioConnect bvMaidstone 50 • 5026 SK Tilburg • The NetherlandsT +31 40 2901570 • F +31 40 2901579 • [email protected] • www.jmbioconnect.com

Solmed® Tubeflex 4502 TECHNICAL DATA COMPOUND CODE : 4502PRODUCT : Solmed® TubeflexMAIN POLYMERS : Thermoplastic ElastomerMAIN APPLICATION AREAS : Biotechnology systems, biopharmaceutical fluid transfer

PHYSICAL PROPERTY* DIMENSION VALUE PROCEDURE

Tensile strength at break MPa 12 ASTM D-638

Elongation at break % 1800 ASTM D-638

Tensile modulus at 100% elongation MPa 1.2 ASTM D-638

Shore A - 60 ASTM D-2240

Cold brittleness °C < -40 ASTM D-746

Density g.cm-3 0.9 ASTM D-792

Water vapor transmission g.m-2.day-1 0.08 ASTM F-1249rate (23°C, 100% RH)

O2 permeability (23°C; 0%RH) cm3.m-2.day-1.bar-1 100 ASTM D-3985

CO2 permeability (23°C; 0% RH) cm3.m-2.day-1.bar-1 350 ASTM F-2476

Steam sterilization shrinkage % � 1 AUTOCLAVE121 °C, 30 minutes

Haze % 30 ASTM D-1003

Water absorption (100% RH) % < 0.2 ASTM D-570

Burst Pressure (23 °C) MPa 0.54 ASTM D-1599

All above tests: tubing size 3/8” x 9/16” (9.5 x 14.3 mm); gamma radiated at >50 kGy.

Solmed® TubeFlex 4502 tubingJM BioConnect developed together with Renolit, a new generation of tubing especially designed for the pharmaceutical and biotech industry, Solmed® TubeFlex 4502 tubing. The Solmed® TubeFlex 4502 tubing is made in a complete controlled cleanroom environment using the cleanest biological compa-tible material TPE which is already widely used within the industry. The Solmed® TubeFlex 4502 tubing is autoclavable, resistant for gamma radiation, weldable (by commercial sterile tube welders) and sealable. Further it is successfully tested and validated as pump tubing and is resistant upto > 3 bar. A complete validation study and extractable study is completed and available for our customers.

Recommended tube sealing method : Heat sealing, impulse sealing, sterile dockingRecommended sterilization method : Gamma, ETO, UVMaximum recommended sterilization temperature : 121°CMaximum recommended sterilization dose : 50 kGyRecommended pH range : 2-13Appearance : Slightly frostedFormulation characteristics : Ultra low extractable, high purity, high flexibility and free of animal derived ingredients and oils.Pump performance : KrosFlo® Research II pump (0-600 rpm) Recommended continuous use : up to 60 hour at 160 rpm Flow rate stability at 200 rpm : better than 93%; tested for 48h. Flow rate stability at 600 rpm : better than 87%; tested for 7h. Tests conducted on tubing size 3/8” x 9/16” : (9.5 x 14.3 mm); gamma radiated at >50 kGy.

Tubeflex 4502 Tubing

Tubing Catalog # ID X OD (metric mm) ID X OD (fractions) m/Coil Packing Qty

3,2 x 6,4

4,8 x 7,9

4,8 x 9,5

6,4 x 9,5

6,4 x 11,1

6,4 x 12,7

7,9 x 12,7

9,5 x 12,7

9,5 x 14,3

9,5 x 15,9

12,7 x 15,9

12,7 x 17,5

12,7 x 19,1

15,9 x 22,2

19,1 x 25,4

19,1 x 28,6

19,1 x 31,8

25,4 x 34,9

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15

15

15

15

15

15

15

15

15

15

15

15

15

15

5

5

5

5

1/8 x 1/4

3/16 x 5/16

3/16 x 3/8

1/4 x 3/8

1/4 x 7/16

1/4 x 1/2

5/16 x 1/2

3/8 x 1/2

3/8 x 9/16

3/8 x 5/8

1/2 x 5/8

1/2 x 11/16

1/2 x 3/4

5/8 x 7/8

3/4 x 1

3/4 x 1 1/8

3/4 x 1 1/4

1 x 1 3/8

CL2149 Datasheet overige landen.indd 1 22-12-2009 15:18:20

JM BioConnect bvP.O. Box 6286 • 5600 HG Eindhoven • The NetherlandsT +31 40 2901570 • F +31 40 2901579 • [email protected] • www.jmbioconnect.comKvK 0987654321 • BTW 12345678 • Bank 987654321

Solmed® Tubeflex 4502 TECHNICAL DATA Recommended tube sealing method : Heat sealing, impulse sealing, sterile dockingRecommended sterilization method : Gamma, Steam, ETO, UVMaximum recommended sterilization temperature : 121°CMaximum recommended sterilization dose : 50 kGyRecommended pH range : 3 to 11Appearance : Slightly frostedFormulation characteristics : Ultra low extractable, high purity, high flexibility. Free of animal derived ingredients and oils.

Pharmacopoeia compliancy and biocompatibility:- ISO 10993-4 Hemolysis- ISO 10993-5 Cytotoxicity- ISO 10993-6 Implantation test- ISO 10993-10 Irritation and Sensitization- ISO 10993-11 Acute Systemic Toxicity- ISO 10993-18 Chemical Characterization- USP <88> class VI; 121 °C, 1 hour- USP <85> Bacterial Endotoxins – LAL- USP <661> plastic containers- European Pharmacopoeia tests 3.1.6- Japanese Pharmacopoeia testsCopies of the test reports are available upon request.

Pump performance Krossflow R II (0-600 RPM)Recommended continuous use up to 60 hour at 160 RPMFlow rate stability at 200 RPM better than 93%; tested for 48h.Flow rate stability at 600 RPM better than 87%; tested for 7h.Tests conducted on tubing size 3/8” x 9/16” (9.5 x 14.3 mm); gamma radiated at >50 kGy.

This technical information consists of typical product data and should not be used as a specification 2009/09.

The data contained in this document are provided in good faith for the sake of general information. It is deemed to be accurate at the time of going into press. The purchaser or user is required to verify with our technical services whether any specific application is appropriate. Freedom of possession, use or marketing under intellectual property rights or legal provisions or regulations, whether national or local, must be duly considered before use. Under no circumstances should any Solmed film, tubing or compound be used in any cosmetic, reconstructive or any other temporary or permanent bodily implant application.

Solmed® TubeFlex 4502 validation & technical data

Physical Property* Dimension Value Procedure







Water vapor transmission g.m-2.day-1 0.08 ASTM F-1249rate (23°C, 100% RH) O2 permeability (23°C; 0% RH) cm3.m-2.day-1.bar-1 100 ASTM D-3985 CO2 permeability (23°C; 0% RH) cm3.m-2.day-1.bar-1 350 ASTM F-2476

Steam sterilization shrinkage % 1 AUTOCLAVE121°C, 30 minutes



Burst Pressure (23°C) MPa 0.54 ASTM D-1599


- ISO 10993-4 Hemolysis- ISO 10993-5 Cytotoxicity- ISO 10993-6 Implantation test- ISO 10993-10 Irritation and Sensitization- ISO 10993-11 Acute Systemic Toxicity- ISO 10993-18 Chemical Characterization

Copies of the test reports are available upon request.

- USP <88> class VI; 121 °C, 1 hour- USP <85> Bacterial Endotoxins – LAL- USP <661> plastic containers- European Pharmacopoeia tests 3.1.6- Japanese Pharmacopoeia tests

This technical information consists of typical product data and should not be used as a specification 2009/09.

The data contained in this document are provided in good faith for the sake of general information. It is deemed to be accurate at the time of going into press. The purchaser or user is required to verify with our technical services whether any specific application is appropriate. Freedom of possession, use or marketing under intellectual property rights or legal provisions or regulations, whether national or local, must be duly considered before use. Under no circumstances should any Solmed film, tubing or compound be used in any cosmetic, reconstructive or any other temporary or permanent bodily implant application.

COMPOUND CODE : 4502PRODUCT : Solmed® TubeflexMAIN POLYMERS : Thermoplastic ElastomerMAIN APPLICATION AREAS : Biotechnology systems, biopharmaceutical fluid transfer


















Pharmacopoeia compliancy and biocompatibility:

CL2149 Datasheet overige landen.indd 2 22-12-2009 15:18:20

Solmed TubeFlex 4502 tubing Solmed TubeFlex 4502 Overig.pdfJM BioConnect bv P.O. Box 6286 • 5600...

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